Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01514084
First received: January 12, 2012
Last updated: April 21, 2014
Last verified: April 2014

January 12, 2012
April 21, 2014
February 2012
November 2013   (final data collection date for primary outcome measure)
Cosmetic outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Cosmetic Visual Analog Score and the Wound Evaluation Score
Same as current
Complete list of historical versions of study NCT01514084 on ClinicalTrials.gov Archive Site
Satisfaction score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"
Same as current
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Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department
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Facial lacerations are commonly treated in the emergency department. The nature of the injury leads to a great deal of concern about the long-term cosmetic appearance of the wounds.

Research Questions

  1. What is the association between wound characteristics, wound management in the ED, patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds?
  2. Is there a difference noted among ED providers with different levels of training?
  3. Is there an association between initial satisfaction scores and wound outcome?
  4. Is there an association between short term and long term wound scores?

Design This is a non-randomized, prospective, observational study of patients who present to the ED seeking treatment for facial laceration repair.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pediatric emergency department

Facial Lacerations
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  • PEM group
    Patients whose lacerations have been repaired by PEM trained physicians.
  • GP group
    Patients whose lacerations have been repaired by general pediatricians.
  • PNP group
    Patients whose lacerations have been repaired by PNPs.
  • RN group
    Patients whose lacerations have been repaired by suture RNs.
Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Families presenting to the ED for repair of facial laceration will be approached for study inclusion if:

    • Their child seeking treatment is less than 18 years of age
    • The laceration was sustained less than 12 hours prior to presentation to Children's ED
    • They speak English

Exclusion Criteria:

  • Families presenting to the ED for repair of facial laceration will be excluded from study participation if they:

    • Are medically complex children
    • Have a history of pre-existing coagulopathy or collagen vascular disease
    • Have a history of immunodeficiency or diabetes mellitus
    • Are suspected of non-accidental trauma
    • Have wounds that could be approximated by tissue adhesives
    • Have animal or human bites
    • Have gross contamination
    • Have puncture wounds
    • Have lacerations of tendon/nerve/cartilage
    • Have scalp lacerations
    • Do not speak English
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514084
1108-081
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Children's Hospitals and Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
Not Provided
Not Provided
Children's Hospitals and Clinics of Minnesota
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP